文献精选 > 近年高分"脑机接口"研究（IF≥30，近5年）

Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage.

文献信息

DOI	10.1056/NEJMoa2308440
PMID	38598795
期刊	The New England journal of medicine
影响因子	78.5
JCR 分区	Q1
发表年份	2024
被引次数	104
关键词	微创手术, 脑出血, 功能结果, 随机试验, 医疗管理
文献类型	Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial
ISSN	0028-4793
页码	1277-1289
期号	390(14)
作者	Gustavo Pradilla, Jonathan J Ratcliff, Alex J Hall, Benjamin R Saville, Jason W Allen, Giorgio Paulon, Anna McGlothlin, Roger J Lewis, Mark Fitzgerald, Angela F Caveney, Xiao T Li, Mark Bain, Joao Gomes, Brain Jankowitz, Georgios Zenonos, Bradley J Molyneaux, Jason Davies, Adnan Siddiqui, Michael R Chicoine, Salah G Keyrouz, Jonathan A Grossberg, Mitesh V Shah, Ranjeet Singh, Bradley N Bohnstedt, Michael Frankel, David W Wright, Daniel L Barrow

一句话小结

这项多中心随机试验评估了急性脑出血患者中微创手术清除血肿与医学管理的效果，结果显示微创手术在180天时的功能结果优于仅接受医学管理的患者，尤其对叶状出血患者效果更显著，术后死亡率也较低。研究表明，早期微创手术可能为急性脑出血患者提供更好的预后，具有重要的临床意义。

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微创手术 · 脑出血 · 功能结果 · 随机试验 · 医疗管理

摘要

背景 对颅幕上脑出血的外科清除试验通常未显示出功能上的益处。早期微创手术切除是否会比医学管理带来更好的结果尚不明确。

方法 在这项涉及急性脑出血患者的多中心随机试验中，我们评估了血肿的外科切除与医学管理的效果。对血肿体积在30至80毫升之间的叶状或前基底节出血患者，在最后一次被确认健康后的24小时内，按1:1的比例分组，接受微创手术清除血肿加指南基础医学管理（手术组）或仅接受指南基础医学管理（对照组）。主要疗效终点为180天时在效用加权修订Rankin量表上的平均得分（范围为0至1，得分越高表示患者评估的结果越好），设定的优越性后验概率阈值为0.975或更高。试验包含根据出血位置调整入组标准的规则。主要安全终点为入组后30天内的死亡。

结果 共招募了300名患者，其中30.7%为前基底节出血，69.3%为叶状出血。在175名患者入组后，触发了适应性规则，仅招募了叶状出血患者。手术组在180天时的效用加权修订Rankin量表的平均得分为0.458，对照组为0.374（差异为0.084；95%贝叶斯可信区间为0.005至0.163；手术的优越性后验概率为0.981）。在叶状出血患者中，两组之间的平均差异为0.127（95%贝叶斯可信区间为0.035至0.219），而在前基底节出血患者中则为-0.013（95%贝叶斯可信区间为-0.147至0.116）。在30天内死亡的患者比例在手术组为9.3%，在对照组为18.0%。手术组有5名患者（3.3%）出现术后再出血和神经功能恶化。

结论 在能够在急性脑出血后24小时内进行手术的患者中，微创血肿清除在180天时的功能结果优于仅接受指南基础医学管理的患者。手术的效果似乎主要归因于对叶状出血的干预。（资助单位：Nico；ENRICH临床试验注册号，NCT02880878。）

英文摘要

BACKGROUND Trials of surgical evacuation of supratentorial intracerebral hemorrhages have generally shown no functional benefit. Whether early minimally invasive surgical removal would result in better outcomes than medical management is not known.

METHODS In this multicenter, randomized trial involving patients with an acute intracerebral hemorrhage, we assessed surgical removal of the hematoma as compared with medical management. Patients who had a lobar or anterior basal ganglia hemorrhage with a hematoma volume of 30 to 80 ml were assigned, in a 1:1 ratio, within 24 hours after the time that they were last known to be well, to minimally invasive surgical removal of the hematoma plus guideline-based medical management (surgery group) or to guideline-based medical management alone (control group). The primary efficacy end point was the mean score on the utility-weighted modified Rankin scale (range, 0 to 1, with higher scores indicating better outcomes, according to patients' assessment) at 180 days, with a prespecified threshold for posterior probability of superiority of 0.975 or higher. The trial included rules for adaptation of enrollment criteria on the basis of hemorrhage location. A primary safety end point was death within 30 days after enrollment.

RESULTS A total of 300 patients were enrolled, of whom 30.7% had anterior basal ganglia hemorrhages and 69.3% had lobar hemorrhages. After 175 patients had been enrolled, an adaptation rule was triggered, and only persons with lobar hemorrhages were enrolled. The mean score on the utility-weighted modified Rankin scale at 180 days was 0.458 in the surgery group and 0.374 in the control group (difference, 0.084; 95% Bayesian credible interval, 0.005 to 0.163; posterior probability of superiority of surgery, 0.981). The mean between-group difference was 0.127 (95% Bayesian credible interval, 0.035 to 0.219) among patients with lobar hemorrhages and -0.013 (95% Bayesian credible interval, -0.147 to 0.116) among those with anterior basal ganglia hemorrhages. The percentage of patients who had died by 30 days was 9.3% in the surgery group and 18.0% in the control group. Five patients (3.3%) in the surgery group had postoperative rebleeding and neurologic deterioration.

CONCLUSIONS Among patients in whom surgery could be performed within 24 hours after an acute intracerebral hemorrhage, minimally invasive hematoma evacuation resulted in better functional outcomes at 180 days than those with guideline-based medical management. The effect of surgery appeared to be attributable to intervention for lobar hemorrhages. (Funded by Nico; ENRICH ClinicalTrials.gov number, NCT02880878.).

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主要研究问题

1. 在这项试验中，针对不同类型的脑出血，早期微创手术的效果与传统治疗相比有何不同？
2. 该研究中，是否考虑了患者的年龄和其他合并症对手术结果的影响？
3. 研究中使用的“效用加权改良Rankin量表”具体是如何评估患者功能状态的？
4. 试验结果显示手术组的死亡率低于对照组，这一发现是否会改变未来的临床实践指南？
5. 在其他类型的脑出血（如脑干出血）中，早期微创手术的效果是否也有研究支持？

核心洞察

研究背景和目的

在以往的研究中，颅内出血的外科清除手术通常未能显示出功能上的益处。本研究旨在评估早期微创手术去除急性颅内出血的效果，比较其与传统医学管理的结果，以确定微创手术是否能带来更好的临床结局。

主要方法/材料/实验设计

本研究为一项多中心随机对照试验，纳入了急性颅内出血患者。研究设计如下：

• 参与者：有30至80毫升的脑出血患者，按1:1的比例在最后一次健康状态后的24小时内分为手术组和对照组。
• 主要终点：180天时的效用加权修正Rankin量表评分，评分范围为0到1，分数越高表示结果越好。
• 适应性规则：根据出血位置调整入组标准，175名患者后仅纳入脑叶出血患者。
• 安全终点：入组后30天内的死亡率。

关键结果和发现

• 共招募300名患者，其中30.7%为前基底节出血，69.3%为脑叶出血。
• 手术组在180天时的平均修正Rankin量表评分为0.458，对照组为0.374，二者差异为0.084（95%贝叶斯可信区间：0.005至0.163），手术组的优越性概率为0.981。
• 脑叶出血患者的评分差异为0.127（95%贝叶斯可信区间：0.035至0.219），前基底节出血患者则为-0.013（95%贝叶斯可信区间：-0.147至0.116）。
• 手术组30天内死亡率为9.3%，对照组为18.0%。手术组中有5名患者（3.3%）出现术后再出血和神经功能恶化。

主要结论/意义/创新性

微创去除术在急性颅内出血患者中能够在180天时显著改善功能结局，相较于传统医学管理显示出优越性。该研究强调了对脑叶出血患者进行早期干预的重要性，为未来的临床实践提供了新的见解。

研究局限性和未来方向

• 局限性：研究主要集中在脑叶出血患者，前基底节出血患者的结果不够明确。
• 未来方向：建议进行更大规模的试验，探索不同类型颅内出血患者的手术效果，以及长期随访研究以评估手术的持久效果和潜在风险。

引用本文的文献

1. Blood Pressure Management in Intracerebral Haemorrhage: when, how much, and for how long? - Chloe A Mutimer;Nawaf Yassi;Teddy Y Wu - Current neurology and neuroscience reports (2024)
2. Neuro-imaging in intracerebral hemorrhage: updates and knowledge gaps. - Mary Penckofer;Khuram S Kazmi;Jesse Thon;Daniel A Tonetti;Casey Ries;Swarna Rajagopalan - Frontiers in neuroscience (2024)
3. Ultrasonic cerebrospinal fluid clearance improves outcomes in hemorrhagic brain injury models. - Matine M Azadian;Nicholas Macedo;Brenda J Yu;Ryann M Fame;Raag D Airan - bioRxiv : the preprint server for biology (2024)
4. Neuroendoscopic Parafascicular Evacuation of Spontaneous Intracerebral Hemorrhage (NESICH Technique): A Multicenter Technical Experience with Preliminary Findings. - Long Wang;Xiaodong Li;Zhongyong Deng;Qiang Cai;Pan Lei;Hui Xu;Sheng Zhu;Tengyuan Zhou;Ran Luo;Chao Zhang;Yi Yin;Shuixian Zhang;Na Wu;Hua Feng;Rong Hu - Neurology and therapy (2024)
5. Formation of Multinucleated Giant Cells after Experimental Intracerebral Hemorrhage: Characteristics and Role of Complement C3. - Xiongjie Fu;Ming Wang;Yingfeng Wan;Ya Hua;Richard F Keep;Guohua Xi - Biomedicines (2024)
6. Parallel activation of helicopter and ground transportation after dispatcher identification of suspected anterior large vessel occlusion stroke in rural areas: a proof-of-concept case with modeling from the LESTOR trial. - Max Henningsen;Matthias L Herrmann;Simone Meier;Ulrike Bergmann;Hans-Jörg Busch;Christian A Taschner;Jochen Brich - Scandinavian journal of trauma, resuscitation and emergency medicine (2024)
7. Code-ICH: A New Paradigm for Emergency Intervention. - Aleksandra Yakhkind;Wenzheng Yu;Qi Li;Joshua N Goldstein;Stephan A Mayer - Current neurology and neuroscience reports (2024)
8. The clinical potential of radiomics to predict hematoma expansion in spontaneous intracerebral hemorrhage: a narrative review. - Samuel A Tenhoeve;Matthew C Findlay;Kyril L Cole;Diwas Gautam;Jayson R Nelson;Julian Brown;Cody J Orton;Michael T Bounajem;Michael G Brandel;William T Couldwell;Robert C Rennert - Frontiers in neurology (2024)
9. A Small Step Toward Rational Characterization of Intracerebral Hemorrhage Phenotypes. - Craig A Williamson - Neurocritical care (2025)
10. Hyper-Acute Stroke Systems of Care and Workflow. - Timothy J Kleinig;Patrick McMullan;Geoffrey C Cloud;Prof Christopher Bladin;Anna Ranta - Current neurology and neuroscience reports (2024)

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